NCT04615325

Brief Summary

This multicenter study will investigate the safety, tolerability, pharmacokinetics, and immunogenicity of RO7303359 following single intravitreal (ITV) injection in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Participants will receive an ITV injection of RO7303359 in the single ascending dose stage and the maximum tolerated dose (MTD) or maximum tested dose (MTeD) of RO7303359 in the expansion stage.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2020

Typical duration for phase_1

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 4, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

December 8, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2023

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

2.1 years

First QC Date

October 29, 2020

Last Update Submit

February 27, 2023

Conditions

Geographic Atrophy

Outcome Measures

Primary Outcomes (7)

  • Percentage of Participants With Ocular Adverse Events

    Up to 12 weeks

  • Percentage of Participants With Systemic Adverse Events

    Up to 12 weeks

  • Percentage of Participants With Dose-limiting Adverse Events (DLAEs),

    Up to 12 weeks

  • Percentage of Participants With Serious Adverse Events (SAEs)

    Up to 12 weeks

  • Percentage of Participants With Adverse Events Leading to Study Discontinuation

    Up to 12 weeks

  • Percentage of Participants With Adverse Events of Special Interest (AESIs)

    Up to 12 weeks

  • Change from Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart

    Baseline, Week 12

Study Arms (4)

Single Ascending Dose Stage

EXPERIMENTAL

Participants will receive a single dose of RO7303359, in multiple escalating cohorts (A-D).

Drug: RO7303359

Expansion Cohort Stage

EXPERIMENTAL

Participants will receive the maximum tolerated dose (MTD) or the maximum tested dose (MTeD) as determined in the single ascending dose stage.

Drug: RO7303359

Optional Cohort E

EXPERIMENTAL

An optional additional cohort may be added with the dose not exceed the MTD or MTeD.

Drug: RO7303359

Optional cohort F

EXPERIMENTAL

An optional additional cohort may be added with the dose not exceed the MTD or MTeD.

Drug: RO7303359

Interventions

RO7303359DRUG

RO730359 will be administered as a single intravitreal injection.

Expansion Cohort StageOptional Cohort EOptional cohort FSingle Ascending Dose Stage

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Visual acuity: BCVA letter score of 19-48 ETDRS letters (Snellen equivalent of 20/125-20/400) using ETDRS charts at a starting distance of 4 meters
  • Well-demarcated area of GA secondary to AMD in the absence of choroidal neovascularization (CNV)
  • GA area must be \>/= 0.5 disc area (1.25 mm\^2)

You may not qualify if:

  • GA in the study eye due to causes other than AMD
  • History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
  • Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, or proliferative diabetic retinopathy
  • Prior treatment with photodynamic therapy, external beam radiation therapy (for intraocular conditions), or transpupillary thermotherapy
  • Evidence of prior or active CNV
  • Previous participation in interventional clinical trials for GA or dry AMD, except for vitamins and minerals, irrespective of the route of administration (i.e. ocular or systemic) within the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Northern California Retina Vitreous Associates

Mountain View, California, 94040, United States

Location

Retinal Consultants Med Group

Sacramento, California, 95825, United States

Location

California Retina Consultants - Santa Maria

Santa Maria, California, 93454, United States

Location

Colorado Retina Associates, PC

Denver, Colorado, 80230, United States

Location

Florida Eye Associates

Melbourne, Florida, 32901, United States

Location

University Retina and Macula Associates, PC

Oak Forest, Illinois, 60452, United States

Location

Associated Retinal Consultants PC

Royal Oak, Michigan, 48073, United States

Location

Sierra Eye Associates

Reno, Nevada, 89502, United States

Location

Western Carolina Retinal Associate PA

Asheville, North Carolina, 28803, United States

Location

Tennessee Retina PC.

Nashville, Tennessee, 37203, United States

Location

Austin Clinical Research LLC

Austin, Texas, 78750, United States

Location

Retina Foundation of the Southwest

Dallas, Texas, 75231, United States

Location

Related Publications (1)

  • Pearlman JA, Sheth VS, Khanani AM, Indjeian VB, Brunstein F, Kuruvilla D, Maia M, Dere R, Ma L, Chen H, Datta S, Willis JR, Wiley HE. Phase I Study of the Anti-interleukin 33 Fragment Antigen-Binding Region RO7303359 in Geographic Atrophy Secondary to Age-Related Macular Degeneration. Ophthalmol Sci. 2025 Apr 20;5(5):100800. doi: 10.1016/j.xops.2025.100800. eCollection 2025 Sep-Oct.

    PMID: 40538770DERIVED

MeSH Terms

Conditions

Geographic Atrophy

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2020

First Posted

November 4, 2020

Study Start

December 8, 2020

Primary Completion

January 4, 2023

Study Completion

January 4, 2023

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).

Locations

US(12)